GUEST CONTRIBUTORS

  • 5 Questions To Ask Your CDMO: #4 – What’s Your Sweet Spot?
    5 Questions To Ask Your CDMO: #4 – What’s Your Sweet Spot?

    Virtually every biotech or pharmaceutical company relies on contract development and manufacturing organizations (CDMOs) for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner.

  • Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies
    Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies

    This is the second of two articles, this part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

  • Biosimilar Coverage By The VA — What You Need To Know
    Biosimilar Coverage By The VA — What You Need To Know

    Merck’s recent announcement that its infliximab biosimilar, Renflexis, was awarded a U.S. Department of Veterans Affairs (VA) national contract has sparked curiosity about the potential influence this might have on biosimilar adoption and formulary preference in the rest of the market. Renflexis was determined to be the lowest-priced infliximab proposed under a competitive solicitation and, as such, was awarded preferred use as the only infliximab option covered on the VA National Formulary (VANF).

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PHARMA OUTSOURCING WHITE PAPERS

Utilizing External Collaboration To Accelerate Vaccine Development Utilizing External Collaboration To Accelerate Vaccine Development

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

Insights And Tips When Addressing Bioburden Challenges

This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

Managing Risk In Biomanufacturing

This white paper focuses on how a structured and transparent risk management process can align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. 

Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

9 Reasons To Consider A Single-Use Fermentor

Dedicated Fermentation Technology Replacing Stainless Steel Systems in Bioprocess Markets

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Understanding And Delivering Your EU Orphan Drug Launch

Although the European marketplace presents a significant opportunity for innovative orphan drug companies to meet unmet patient needs, launching your drug product can present a real challenge.

Detecting Pro-Cognitive Effects In Clinical Drug Trials: Case Studies From Alzheimer’s Disease
There has been turmoil in the world of Alzheimer’s disease (AD) clinical drug trials over the past couple of years. Not too long ago we believed we had a good handle on the pathology that underlies brain cell death in this devastating disease – and better yet, drugs that could remove the pathological hallmarks.
Flexibility In Biologics Manufacturing: How To Determine If Stainless, Flexible Stainless, Or Single-Use Is Right For You

Meet customer needs by providing manufacturing options to suit every preference.

How To Avoid 5 LIMS Nightmares

Analysts have estimated the failure rate of commercial laboratory information management systems (LIMS) to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • How Biopharma Is Capitalizing On The Antibody Boom
    How Biopharma Is Capitalizing On The Antibody Boom

    Antibodies continue to dominate. Analyzing the strategies employed by successful players in the field could provide invaluable lessons for those hoping to enter it.

  • How Biogen Integrated Process Analytics Technology With End-To-End Supply Chain Transparency
    How Biogen Integrated Process Analytics Technology With End-To-End Supply Chain Transparency

    To drive appropriate and dependable critical process control requirements, Biogen explored several novel strategies to increase process and raw material control and optimize communication of data throughout the supply chain.

  • The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing
    The Past And Future Of Managing Raw Material And Process Risks In Biomanufacturing

    How far have we come in raw material supply management, and what still needs accomplished to ensure the delivery of safe and effective drugs?

  • Why Invest In Emerging Markets Now
    Why Invest In Emerging Markets Now

    Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

  • Ozonolysis Development Solutions For Safety Studies And Scale Up
    Ozonolysis Development Solutions For Safety Studies And Scale Up

    Ozonolysis is a widely used reaction in organic synthesis. The reaction was invented by Christian Friedrich Schoenbein in 1840. Alkenes and alkynes are the most common substrates for the ozonolysis reaction. Ozonolysis was an important diagnostic tool for the determination of the position of unsaturation in unknown molecules before the invention and development of spectroscopic techniques for identification and characterization of organic molecules. The reaction was used for structure elucidation work because it provided chemists with smaller and more readily identifiable carbonyl compounds.

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